With the rapid advancement of assisted reproductive technology (ART),an increasing number of infertile couples have achieved parenthood.Estradiol preparations play an irreplaceable role in key clinical procedures,including endometrial preparation for hormone replacement therapy-frozen-thawed embryo transfer (HRT-FET) and luteal phase support.However,the diversity of these agents and their routes of administration has led to prevalent off-label use and a lack of standardized guidance.To standardize the clinical use of estradiol in ART,the Consensus Development Group,following the World Health Organization (WHO) guideline development methodology,identified nine core clinical questions through a literature review and expert consultations.We systematically reviewed international and national databases to synthesize the best available evidence.Focusing on key aspects such as endometrial preparation protocols for HRT-FET,optimized management strategies for thin endometrium,indications and timing of estrogen administration in luteal phase support,and its application in GnRH antagonist protocols,the consensus ultimately formulated 15 recommendations.It clarified medication selection,routes of administration,dosage regimens,and treatment durations for various clinical scenarios.This consensus aimed to provide clinicians and pharmacists with practical,evidence-based references,facilitate the development of individualized treatment plans,optimize ART outcomes,ensure patient medication safety,and ultimately contribute to improving reproductive health services in China.
Objective To investigate the effects of Euphorbium total triterpenoids (TTE) on the proliferation,apoptosis,migration,and invasion of MH7A cells (rheumatoid arthritis fibroblast-like synoviocytes,RA-FLS). Methods The experimental concentrations of TTE were determined as 6.25,12.5,and 25 μg·mL-1 based on CCK-8 results.Furthermore,cell migration and invasion were evaluated using a scratch wound-healing assay and a Transwell invasion assay,respectively,while apoptosis was detected by flow cytometry.The levels of tumor necrosis factor-alpha (TNF-α),interleukin-1beta (IL-1β),and interleukin-6 (IL-6) in the cell culture supernatant were measured using enzyme-linked immunosorbent assay (ELISA).Western blotting assay was used to detect the protein expression of PI3K,p-Akt,p-mTOR,MMP-3,MMP-9,and Cleaved Caspase-3 in MH7A cells. Results Compared with the blank control group,TTE significantly inhibited the proliferation,migration,and invasion of MH7A cells and promoted their apoptosis (P<0.05).TTE (12.5 μg·mL-1) could also effectively reduce the level of TNF-α,IL-1β,and IL-6 in the cell supernatant(P<0.05),inhibit the expression of migration- and invasion-related proteins MMP-3 and MMP-9 (P<0.05),and promote the expression of the apoptosis-related protein Cleaved Caspase-3 (P<0.05).Moreover,TTE (25 μg·mL-1) could down-regulate the expression of PI3K,p-Akt,and p-mTOR proteins in MH7A cells (P<0.05). Conclusions Preventive mechanisms of TTE in RA involve inhibiting the proliferation,migration,and invasion of MH7A cells,as well as promoting their apoptosis.These findings provide a basis for further development of TTE.
Objective To explore the mechanism of the orphan nuclear receptor Nur77 targeting epithelial-mesenchymal transition to combat liver fibrosis. Methods Forty C57/BL6 mice were randomly divided into four groups: negative control (NC),hepatic fibrosis model (NM),Nur77 overexpression control (OEC),and Nur77 overexpression model (OEM),with 10 mice per group.Hepatic fibrosis was induced in mice via intraperitoneal injection of carbon tetrachloride in olive oil.The OEC group received an intravenous injection of 200 μL of Nur77 overexpression virus,while the NC and NM groups received an intravenous injection of 200 μL of a negative control virus.Following the intervention,hepatic function and pathological alterations were assessed.Protein levels of α-SMA,E-cadherin,Nur77,and PI3K were detected using Western blotting and immunofluorescence.For cellular experiments,human hepatic stellate cells (LX-2) were activated and cultured with PDGF-BB. Results ① After 8 weeks of model induction,the body weight of the NM group was significantly lower than that of the NC and OEM groups (both P<0.05).② Compared to the NM group,the levels of ALT and AST in the OEM group were significantly reduced (both P<0.05).HE staining revealed that,compared with the NM group,the OEM group exhibited reduced severity of pathological injury and decreased collagen fiber distribution.③ Western blotting and immunofluorescence assays demonstrated that α-SMA protein expression was significantly elevated in the NM group compared to the NC group (P<0.05),and α-SMA expression was markedly reduced in the OEM group relative to the NM group (P<0.05).④ Immunohistochemical staining indicated that the number and expression level of E-cadherin positive cells were significantly decreased in the NM group compared to the NC group;the yellow positive staining area was notably increased in the OEM group compared to the NM group (P<0.05).⑤ Nur77 protein expression was significantly reduced in the NM group compared to the NC group;Nur77 protein expression was markedly increased in the OEM group relative to the NM group.⑥ RNA-seq analysis revealed significant enrichment of the PI3K/Akt signaling pathway;Western blotting analysis showed that p-Akt/Akt and p-PI3K/PI3K were significantly elevated in the NM group compared to the NC group (P<0.05);in contrast to the NM group,the OEM group exhibited a significant decrease in p-PI3K/PI3K and p-Akt/Akt (P<0.05). Conclusions Nur77 inhibits epithelial-mesenchymal transition in a mouse model of liver fibrosis.Its mechanism involves the regulation of the PI3K/Akt signaling axis,offering novel strategies and intervention targets for the precise treatment of liver fibrosis.
Objective To explore the effect and mechanism of Danggui Futongning dropping pills (DNFD) in the treatment of primary dysmenorrhea. Methods ①Analgesic and anti-inflammatory experiments: 60 Kunming mice were randomly divided into a model control group,DNFD low-,medium-,and high-dose groups,and an aspirin group,12 mice in each group.The analgesic and anti-inflammatory effects of DNFD were evaluated by intraperitoneal injection of 0.8% glacial acetic acid(0.01 mL·g-1),the hot plate method,and the ear swelling method.②Treatment of primary dysmenorrhea experiment: 72 SD rats were randomly divided into a normal control group,a model control group,a low-dose,a medium-dose and a high-dose DNFD group and a Yimucao granules group.Except for the normal control group,the other groups were subcutaneously injected with estradiol valerate 2.0 mg·kg-1 on the 1st and 10th day,and estradiol valerate 1.0 mg·kg-1 on the 2nd to 9th days.The primary dysmenorrhea model was induced by the combined injection of estradiol valerate and oxytocin.From the 4th day of injection,the normal control group and the model control group were given an equal volume of 0.9 % sodium chloride solution,and the other groups were given different doses of DNFD solution 2 mL for 7 consecutive days.To evaluate the effects of DNFD on writhing response,pathological changes of uterine tissue,contents of β-endorphin (β-EP),estradiol (E2),progesterone (PROG) and interleukin-6 (IL-6) in serum,contents of prostaglandin E2 (PGE2),cyclooxygenase-2 (COX2),15-hydroxyprostaglandin dehydrogenase (PGDH) and cyclooxygenase-1 (COX1) related to prostate metabolism,levels of oxidative stress superoxide dismutase (SOD) and malondialdehyde (MDA),and expressions of proteins related to Janus kinase (JAK) -nuclear factor kappa B signal transducer and activator of transcription signaling pathway/mitogen-activated protein kinase signaling pathway (NF-κB/STAT/MAPK) pathway in uterine tissue. Results ① Compared with the model control group,after administration of DNFD,the number of writhings in mice decreased,the degree of ear swelling decreased significantly (P<0.01),and the inhibition rate of ear swelling and pain threshold increased significantly (P<0.01). ② Compared with the normal control group,the writhing times of rats in the model control group were significantly increased (P<0.01),the levels of E2,IL-6,tumor necrosis factor-α (TNF-α) and PGE2 in serum were significantly increased,the levels of PGDH,COX2 and COX1 mRNA were significantly increased (P<0.01),and the contents of β-EP and PROG were significantly decreased (P<0.01).The content of MDA increased,and the activity of SOD decreased significantly (P<0.01).The infiltration of inflammatory cells in uterine tissue was obvious;the expression of NF-κB,STAT3,JAK1,JAK2,N-terminal kinase (JNK),extracellular signal-regulated kinase (ERK),p38 mitogen-activated protein kinase (P38) and Bcl-2-associated X (BAX) protein in uterine tissue increased significantly,and the content of Bcl-2 decreased significantly.Compared with the model control group,after the administration of DNFD,the levels of E2,IL-6,TNF-α and PGE2 in serum decreased,the levels of PGDH,COX2,and COX1 mRNA decreased significantly (P<0.01),and the contents of β-EP and PROG increased significantly (P<0.01).The content of MDA decreased,and the activity of SOD increased significantly (P<0.01).And the histopathological improvement was obvious;the expression of NF-κB,STAT3,JAK1,JAK2,JNK,ERK,P38,and BAX protein in uterine tissue was significantly decreased,and the content of Bcl-2 was increased. Conclusion DNFD has analgesic and anti-inflammatory effects,and it exerts anti-dysmenorrhea effects by synergistically inhibiting NF-κB/STAT3/MAPK inflammatory signaling network and apoptosis.
Objective To investigate the pharmaceutical care provided by clinical pharmacists for a child with bronchopneumonia caused by multiple pathogens. Methods Clinical pharmacists delivered whole-process pharmaceutical care for a child with bronchopneumonia attributed to multiple pathogens,including drug-resistant bacteria.Based on clinical evidence,literature analysis,and in conjunction with etiological findings,precise recommendations regarding the selection and duration of antimicrobial therapy were proposed to the medical team,aiming to ensure the safety,efficacy,and cost-effectiveness of medication. Results After the physician adopted the recommendation to add cefotiam,the child's condition improved significantly.The pharmacist prudently evaluated the rationality of initiating fluconazole solely based on next-generation sequencing results,but this recommendation was not adopted by the physician. Conclusion The clinical pharmacist promptly identified and bridged a treatment gap in the child's antibiotic therapy,and considering the methodological limitations of next-generation sequencing,recommended dynamic monitoring instead of immediate antifungal therapy,thereby demonstrating the dual professional value of maintaining the continuity of the anti-infective regimen while avoiding overtreatment.
Objective To explore the pharmaceutical care provided by clinical pharmacists for pediatric patient with osteomyelitis,pneumonia,and central nervous system involvement caused by hematogenous Staphylococcus aureus (SA) bloodstream infections. Methods Clinical pharmacists were actively involved in the diagnosis and treatment of a 13-year-old male pediatric patient with disseminated systemic SA infection.Anti-infective therapy was optimized via therapeutic drug monitoring (TDM) and pharmacokinetic/pharmacodynamic (PK/PD) analysis of antibiotics at infection sites,and pharmacists collaborated with clinicians to develop individualized treatment plans. Results The physician implemented the pharmacist's recommendations.The patient's infection was satisfactorily controlled without obvious adverse drug reactions,resulting in successful hospital discharge. Conclusion By providing comprehensive pharmaceutical care throughout the entire treatment course for patients with severe infections,clinical pharmacists ensured the therapeutic efficacy and safety of antimicrobial therapy,serving as a critical safeguard for clinical outcomes.
Objective To explore the key points of monitoring for clinical pharmacists in the anti-infection and analgesic treatment of neonatal patients with incontinentia pigmenti. Methods By reviewing domestic and international literature,clinical pharmacists provided evidence-based guidance on the anti-infective and analgesic treatment of two neonates with incontinentia pigmenti,and monitored the effectiveness and safety of drug treatment in the children. Results The skin lesions of the two children improved significantly compared with before,the pain score decreased,and there were no obvious adverse drug reactions. Conclusion Clinical pharmacists provided individualized medication recommendations for local or systemic anti-infection treatment and analgesic regimens for neonates with incontinentia pigmenti,which provided a reference for the treatment of this rare disease.
Objective To explore the pharmaceutical care model provided by clinical pharmacists in the treatment of pediatric acute generalized exanthematous pustulosis (AGEP),providing a reference for clinical practice. Methods A clinical pharmacist was fully involved in the diagnosis and treatment process of a pediatric patient who developed AGEP following hospitalization for a respiratory tract infection.By systematically reviewing the patient's current treatment course and medical history,combined with relevant literature,potential suspected allergenic drugs were screened step-by-step.Pharmaceutical care and personalized medication guidance were implemented throughout this process. Results The physicians adopted the clinical pharmacist's recommendations,discontinued the suspected offending drug,and adjusted the treatment regimen accordingly.The patient's skin lesions and respiratory infection symptoms gradually subsided,and the patient was discharged successfully. Conclusion In the diagnosis and treatment of pediatric AGEP,clinical pharmacists can assist physicians in more accurately identifying suspected allergenic drugs and in formulating tailored pharmaceutical care plans,thereby improving the overall quality of treatment.
Depression is a common and serious mental disease that greatly affects the quality of life of patients and causes a great social burden.This paper summarizes the changes in the diagnostic criteria for depression and discusses the use of biomarkers,imaging methods,and artificial intelligence in the clinical diagnosis.Additionally,it points out the recent progress in the development of antidepressant drugs,such as new target-oriented therapies and novel formulations with quicker action and fewer side effects.The purpose of this review is to offer a guide and a source of information for the diagnosis and pharmacological treatment of depression.
Drug-induced cholestasis (DIC) is an important subtype of drug-induced liver injury,with complex pathogenesis and a lack of effective treatment.The homeostasis imbalance of bile acids (BAs) is a key driving factor in the occurrence and development of DIC.Recent studies have found that dysbiosis of the gut microbiota is closely associated with BAs imbalance in DIC.This article reviews the impact of BAs imbalance on the development of DIC,focusing on the interaction mechanisms between BAs and the gut microbiota: on one hand,the gut microbiota regulates BAs metabolism,and on the other hand,BAs in turn shape the microbiota structure.Additionally,this interaction is analyzed in terms of its potential mechanisms in DIC progression,including inflammation activation,barrier disruption,and signaling pathway disorders.Finally,potential therapeutic strategies targeting the gut microbiota are discussed,aiming to provide insights and references for the basic research and clinical practice of DIC.
Objective To comprehensively synthesize the existing evidence on the population pharmacokinetics (PPK) of sildenafil (SIL) used in the treatment of pediatric pulmonary arterial hypertension (PAH) and to identify the key determinants of its pharmacokinetic variability. Methods A systematic literature search was conducted in PubMed,Web of Science,Embase,China National Knowledge Infrastructure (CNKI),Wanfang Data,and the Chinese Biomedical Literature Database (SinoMed) from inception to November 17,2025.PPK studies were included.Data on study design,population characteristics,and final parameter estimates were extracted.Monte Carlo simulations were performed to generate visualized predictive distributions for comparison across eligible studies.Forest plots were constructed to assess the impact of covariates on SIL pharmacokinetic parameters. Results Six PPK studies involving preterm neonates,neonates,infants,children,and adolescents were included.The median body weight-normalized apparent clearance (CL/F) of SIL in preterm neonates was 0.44 L∙h-1∙kg-1,representing reductions of 71.6%,70.1%,and 85.2% compared with neonates,children,and infants,respectively.Body weight,postnatal age (PNA),and concomitant fluconazole use were identified as key determinants of the CL/F of SIL and its active metabolite,N-desmethyl sildenafil. Conclusions SIL dosing in pediatric patients with PAH should be individualized based on the identified covariates.Moreover,further pharmacokinetic studies are warranted to elucidate the dose-exposure-response relationship of SIL,thereby optimizing precision dosing in children.
The development and progression of breast cancer is not a sudden malignant event but rather a dynamic process of inflammation-cancer transformation,in which persistent chronic inflammation drives a gradual transition from functional dysregulation to structural malignancy and ultimately to systemic regulatory imbalance.From an integrative Chinese and Western medicine perspective,this article takes the theory of Depression and Toxin Leading to Deficiency as its core framework to systematically elucidate the pathogenic evolution of inflammation-cancer transformation in breast cancer.It is proposed that disease progression follows a continuous evolutionary chain characterized by depression as the initiating basis,toxin as the driver of pathological transformation,and deficiency as the fundamental pathological essence.Furthermore,this theoretical framework aligns with the inflammatory,toxin-accumulation,and cancerous stages of breast cancer,thereby clarifying the dominant pathological states and their intrinsic mechanistic associations at each stage.On this basis,and informed by Professor Song Enfeng's extensive clinical experience,a stage-specific and stratified therapeutic strategy is constructed: in the inflammatory stage,priority is given to soothing the liver,relieving depression,and regulating the pathological state to prevent transformation;in the toxin-accumulation stage,emphasis is placed on combined detoxification and targeted intervention;and in the cancerous stage,reinforcement of vital qi and regulation of the pathological state are regarded as the core therapeutic principles.Methodologically,this theoretical framework is highly consistent with Academician Tong Xiaolin's concept of “state-target differentiation and treatment,” providing an integrative theoretical paradigm for understanding inflammation-driven carcinogenesis in breast cancer from a dynamic evolutionary perspective and for guiding stage-specific traditional Chinese medicine interventions.
Objective Drug cocrystal technology has emerged as a promising strategy in pharmaceutical research for modulating the physicochemical properties of active pharmaceutical ingredients without altering their pharmacological activity.This study aimed to address the poor solubility of furosemide (FSM) and the high hygroscopicity of norfloxacin (NOR) by developing a novel FSM-NOR cocrystal hydrate. Methods The FSM-NOR cocrystal hydrate was synthesized using the solvent evaporation method.Its structure was characterized by single-crystal X-ray diffraction,powder X-ray diffraction,and infrared spectroscopy.The cocrystal was further evaluated by determining apparent solubility and dissolution concentration,intrinsic dissolution rate,hygroscopicity,and antibacterial activity. Results The determination of apparent solubility and dissolution concentration showed that at pH 1.2,the equilibrium concentration of furosemide in the cocrystal hydrate was enhanced 110-fold compared with that in the pure FSM,and accompanied by a 176-fold increase in intrinsic dissolution rate.Hygroscopicity studies demonstrated that the cocrystal hydrate exhibited a weight gain of less than 2%,representing a significant improvement over pure NOR.Antibacterial activity assays revealed that the FSM-NOR cocrystal hydrate maintained inhibitory efficacy against Staphylococcus aureus,Shigella dysenteriae,and Pseudomonas aeruginosa comparable to that of pure NOR. Conclusion The FSM-NOR cocrystal hydrate successfully improves both solubility and stability through complementary effects,while preserving antibacterial activity,thereby validating the potential of cocrystal technology to optimize multicomponent pharmaceutical formulations.
Objective To optimize the process conditions for the enrichment and purification of terpenoids from Tinosporae Radix using D101 macroporous resin,and to evaluate the antioxidant and anti-inflammatory activities of the enriched terpenoid fraction. Methods The effects of impurity removal ethanol concentration,elution ethanol concentration,and elution ethanol column volume on the extraction and purification of columbin were investigated with the yield of columbin as the evaluation index.The model was established,and the optimal conditions were determined by response surface methodology.The characteristic spectrum of the elution site was established,and the antioxidant activity of the purified product was evaluated by the 1,1-diphenyl-2-picrylhydrazyl (DPPH) radical and the 2,2'-azino-bis(3-ethylbenzothiazoline-6-sulfonic acid) diammonium salt (ABTS) radical scavenging methods.The spectrum-effect relationship between the chemical composition and antioxidant activity of Tinosporae Radix was analyzed by grey correlation analysis.The levels of the inflammatory mediator nitric oxide (NO) in lipopolysaccharide (LPS)-induced BV2 cells were measured by the Griess method,and the levels of tumor necrosis factor (TNF)-α and interleukin (IL)-6 in the cell culture supernatant were measured by enzyme-linked immunosorbent assay (ELISA). Results The optimal enrichment and purification process for terpenoids in Tinosporae Radix was as follows: a 0.1 g·mL-1 Tinosporae Radix extract sample solution was prepared.Then the sample was loaded at a rate of 2 BV·h-1 about 10 mL. After that,4 BV of water and 5 BV of 30% ethanol were used for impurity removal,and 6 BV of 80% ethanol was used for elution. The columbin content in the fraction can reach 54.91%,and the yield is 90.05%. Nine common peaks were identified from the fingerprint profiles of the elution site.The results of in vitro activity assays shows that the terpenoid-enriched fraction from Tinosporae Radix significantly reduced the levels of NO,TNF-α,and IL-6 in BV2 cells. Grey correlation analysis showed that peaks 3,4,8 and 9 were associated with antioxidant activity. Conclusions The process is stable and feasible,and can be used to enrich terpenoids in Tinosporae Radix. A spectrum-effect relationship study shows that the components in Tinosporae Radix are related to antioxidant activity,specifically columbin.
Objective To establish and validate a high-performance liquid chromatography-mass spectrometry (HPLC-MS/MS) method for the determination of a potential nitrosamine impurity 4-[(1-amino-1-oxobutan-2-yl)(nitroso)amino]butanoic acid in levetiracetam concentrated solution for injection. Methods Separation was achieved on a ZORBAX Eclipse plus C8 column (4.6 mm × 150 mm,3.5 μm) using a gradient elution with mobile phase A (5 mmol·L-1 ammonium acetate) and B (methanol) at a flow rate of 0.5 mL·min-1.The column temperature was set at 40 ℃,and the injection volume was 10 μL.Detection was performed by electrospray ionization (ESI) in negative-ion mode with multiple reaction monitoring (MRM).The transition m/z 215.9 → 42.0 was monitored for quantification. Results The method demonstrated good linearity over the range of 0.25 to 9.93 ng·mL-1 (r=0.999 6).The limit of detection (LOD) and limit of quantification (LOQ) were 0.125 ng·mL-1 and 0.25 ng·mL-1,respectively.The recovery ranged from 92.8% to 98.1%.The method showed satisfactory precision and stability.The target nitrosamine impurity was not detected in either the reference-listed drug or the self-developed products. Conclusion The developed method is simple,sensitive,and accurate,making it suitable for the quality control of the specified nitrosamine impurity in levetiracetam concentrated solution for injection.
Objective To analyze the labeling of glucose-6-phosphate dehydrogenase (G6PD) deficiency in the package inserts of Chinese Patent Medicines(CPMs) suitable for pediatric in the Pharmacopoeia of the People's Republic of China (2025 ed),National Essential Medicine List (2026 ed),and National Basic Medical Insurance,Employment Injury Insurance and Maternity Insurance Medicine List (2025 ed)(referred to as “one pharmacopoeia and two lists”),and assign risk scores to CPMs that may induce hemolysis due to G6PD deficiency. Methods We established the "G6PD risk CPMs database" in Excel by collecting package inserts for pediatric CPMs listed in the "one pharmacopeia and two lists",and the scoring criteria were based on evaluation criteria such as the“Clinical Comprehensive Evaluation Guidelines for CPM (2022 Edition Trial)”.Scoring is conducted across two primary dimensions-safety and suitability-and three secondary dimensions: risk factors,number of risk components,and clinical medication guidance. Results The “one pharmacopeia and two lists” collectively list 342 (deduplicated) CPMs suitable for pediatric use,including 119 G6PD-risk formulations.According to the scoring criteria,G6PD risk traditional Chinese medicines scored 3-4 points,which accounted for 58.0%;5-6 points accounted for 31.9%;and 7 points or above accounted for 10.1%.In terms of the labels of package inserts,only 2 CPMs suitable for pediatric use have indicated the relevant information for pediatric patients with G6PD deficiency. Conclusions Although research on the hemolytic risk associated with G6PD deficiency in the package insert for pediatric CPMs remains insufficient,this study found that some CPMs still indicate a relatively high risk of hemolysis.It is recommended to strengthen relevant research and clearly standardize risk information in the package insert to ensure the safety of pediatric medication.
Objective To analyze the current status of DAAs treatment for patients with chronic hepatitis C and survey their knowledge of hepatitis C and drug therapy. Methods Patients who diagnosed with chronic hepatitis C and prescribed DAAs and visited pharmacy outpatient clinic of Sichuan Provincial People's Hospital from June 2023 to May 2025 were selected.Clinical pharmacists conducted on-site or telephone surveys to collect clinical data from the patients.The Morisky-8 medication adherence scale was used to assess patients' adherence to DAAs therapy,and a self-designed public health literacy survey was used to assess their health knowledge and awareness levels.Medication education was provided to the patients.The influencing factors of medication adherence and health knowledge levels in patients with chronic hepatitis C were analyzed using univariate and multivariate ordinal Logistic regression. Results A total of 105 patients with chronic hepatitis C were included in the study.The most commonly prescribed DAAs were sofosbuvir/velpatasvir (61.90%),and the most frequent concomitant medications were calcium channel blockers (18.10%).Polypharmacy was observed in 15.24% of patients,while 11.43% were at risk of potential drug-drug interactions.Regarding DAAs adherence levels,55.24% of patients were classified as "good",30.48% as "moderate",and 14.29% as "poor".Regarding health knowledge awareness,19.05% were rated "good",61.90% "moderate",and 19.05% "poor".Logistic regression analysis revealed that educational level and sources of hepatitis C knowledge were significantly associated with health knowledge awareness scores (P<0.05).Meanwhile,age and occupation were significantly correlated with DAAs adherence scores (P<0.05). Conclusions Patient adherence to DAAs regimens among chronic hepatitis C patients was generally favorable,whereas health-related knowledge was moderate.Healthcare providers should strengthen health education for patients,especially for individuals with limited education,and strive to expand patients' access to knowledge.Clinical pharmacists should play an active role in identifying and managing drug-drug interactions,as well as in providing medication education and follow-up management for DAAs.
Objective To evaluate the comprehensive clinical value of the domestic class 1 innovative drug encofosbuvir combined with netanasvir phosphate in the treatment of chronic hepatitis C using the Multi-Criteria Decision Analysis (MCDA) framework. Methods Using the framework of the Rapid Guidelines for Drug Evaluation and Selection in Chinese Medical Institutions (Third Edition),Chinese and English databases were systematically searched,with the inclusion explicitly limited to clinical randomized controlled trials and high-quality real-world studies,to acquire evidence-based data.A multidisciplinary panel of 15 experts was selected to conduct a two-round Delphi survey,and the Analytic Hierarchy Process (AHP) was utilized to establish the indicator weights.After synthesizing efficacy and safety data via systematic review and meta-analysis,a cost-minimization analysis (CMA) based on a decision tree model was performed to calculate direct medical costs.On this basis,an MCDA quantitative evaluation model was constructed to perform multi-criteria aggregation using a weighted sum method for multidimensional scoring,with a threshold of " ≥ 80 points" set as the criterion for being strongly recommended for inclusion in the medical institution's formulary. Results All AHP judgment matrices passed the consistency test (consistency ratio,CR<0.1),establishing weights for the primary indicators: efficacy (28.0%),safety (27.0%),pharmaceutical characteristics (27.0%),economy (10.0%),and other attributes (8.0%).The sustained virologic response rate at 12 weeks (SVR12) of this regimen in pan-genotypic chronic hepatitis C patients reached 95.02%,demonstrating clinical efficacy comparable to the clinical standard regimen.Given equivalent clinical benefits,the direct medical cost of this regimen for a 12-week standard treatment course (6 300.00 RMB) was lower than that of the model comparator (sofosbuvir/velpatasvir,9 277.80 RMB),demonstrating a distinct cost-saving advantage.The final comprehensive MCDA score of this regimen was 81.5 points (compared to 78.3 points for the model comparator),meeting the threshold for being strongly recommended for inclusion in the medical institution's formulary. Conclusions Encofosbuvir combined with netanasvir phosphate demonstrates efficacy and safety comparable to current clinical standard therapies in the treatment of chronic hepatitis C,along with a significant medical cost-saving advantage. It is strongly recommended for inclusion in the medical institution's formulary.
Objective To construct and implement a resident pharmacist-led "Assessment-Intervention-Monitoring" nutritional pharmacy work model in medical oncology,and to evaluate its role and value in improving nutritional therapy for oncology patients. Methods To establish a work model led by resident pharmacists and supported by collaboration among physicians,pharmacists,and nurses.Within 24 hours of admission,patients underwent nutritional risk screening and comprehensive nutritional assessment.Individualized nutritional intervention plans were implemented using the five-step nutritional intervention strategy (nutritional education-oral nutritional supplements-enteral nutrition-partial parenteral nutrition-total parenteral nutrition) accompanied by comprehensive pharmaceutical monitoring.The model's effectiveness was evaluated by comparing key indicators before and after its implementation. Results The model was implemented from July 2024 to June 2025.During this period,pharmacists directly served 533 patients.The enteral nutrition usage rate in the ward increased from 5.1% to 13.4%,and the parenteral nutrition usage rate increased from 2.06% to 2.99%.Patient compliance with oral nutritional supplements increased from 12.3% to 41.8%,and the rational rate of parenteral nutrition prescriptions rose from 90.6% to 99.5%.Among the 152 patients receiving parenteral nutrition,no nutrition-related complications occurred.During this period,the department reported the highest number of Adverse Drug Reactions (ADRs) in the hospital. Conclusion This model effectively expanded the coverage of nutritional interventions for oncology patients,enhanced the level of process standardization and patient compliance,and ensured the timeliness of interventions and treatment safety.
Objective To explore the collaborative role and practical path of clinical pharmacists in the perioperative nutritional therapy of children with short bowel syndrome (SBS) complicated by high refeeding risk and severe malnutrition,and to provide a reference for nutritional intervention in special pediatric populations. Methods A 16-year-old child with SBS caused by intestinal ischemic necrosis and severe malnutrition (with a remaining small intestine of 100 cm and no ileocecal valve) was enrolled.Within the multidisciplinary team (MDT) management framework,clinical pharmacists assisted with nutritional and refeeding risk screening,provided evidence-based recommendations aligned with international guidelines,and participated in the formulation and optimization of a "low-initiation,stepwise increment,stable reinforcement" parenteral nutrition (PN) plan.They collaborated to dynamically monitor indicators such as body weight,electrolytes,and serum proteins,provided adjustment suggestions based on laboratory results and clinical status,tracked the entire course of the first and second surgeries and the 6-month postoperative follow-up,and assisted in evaluating the efficacy of nutritional support. Results After 21 days of preoperative PN support in the first stage,the child's body weight increased from 32.0 kg to 36.8 kg,electrolyte disorders were completely corrected,alanine aminotransferase and aspartate aminotransferase levels returned to normal from 100 U·L-1 and 107 U·L-1,respectively,and the surgery was successfully completed.After 33 days of nutritional intervention before the second-stage surgery,body weight increased from 29.4 kg to 41.0 kg.Postoperatively,the child gradually transitioned to enteral nutrition,and the body weight reached 47.0 kg at 6 months of follow-up with complete recovery of nutritional status.No complications such as refeeding syndrome or PN-related liver disease occurred during the whole process. Conclusion In the perioperative treatment of children with SBS complicated by severe malnutrition,clinical pharmacists can help improve the scientificity and safety of nutritional therapy by assisting with risk assessment,providing suggestions for plan optimization,and collaborating on whole-course monitoring,thereby offering pharmaceutical support to the MDT team with practical clinical value.
Objective To construct a risk evaluation indicator system for drug clinical trial institutions,calculate the risk values of all institutions undergoing routine regulatory inspection in Jiangsu Province from 2021 to 2024,and verify the effectiveness of the system. Methods A preliminary indicator pool was established through literature review and policy analysis.The Delphi method was used to optimize the indicator system,and the analytic hierarchy process (AHP) was applied to determine indicator weights.Taking all inspected institutions in Jiangsu Province from 2021 to 2024 as samples,comprehensive risk values were calculated.The ranking of these values was compared against actual inspection conclusions. Results Through expert consultation and validation,an evaluation system consisting of three warning indicators and general indicators across six dimensions was established.Empirical results showed that institutions with high computed risk scores were significantly more likely to be subjected to risk control measures.The agreement rates between risk value rankings and inspection results over the four years were 83.3%,90.0%,91.7%,and 89.5%,respectively. Conclusions The constructed indicator system meets the requirements for institutional risk monitoring and prevention.The indicator data are readily accessible,and the calculated results are of practical value,making the system applicable for risk evaluation of drug clinical trial institutions in Jiangsu Province.
Objective To establish a full-process traceability management system for narcotic drugs and Class I psychotropic drugs (hereinafter referred to as "narcotic and psychotropic drugs") in the operating room based on single-unit coding technology and multi-system information integration,and to evaluate its effectiveness in application. Methods A hospital-initiated secondary coding strategy was adopted,assigning a unique traceability code (UTC) to each drug usage unit.The hospital information system (HIS),anesthesia information management system (AIMS),and intelligent medicine cabinet system were integrated to construct a digital closed-loop management workflow.A quasi-experimental pre-post design was used.Operational data were retrospectively collected for three months before (control period) and three months after (intervention period) system implementation.A multidimensional evaluation index system based on the structure-process-outcome (SPO) model was developed to compare changes in management quality and operational efficiency.Additionally,the technology acceptance model (TAM) was used to conduct a user satisfaction survey among healthcare providers. Results After implementation,the accuracy rate of batch number management for controlled substances in the operating room increased from 63.5% to 100.0%.the empty ampoule recovery rate improved from 92.1% to 100.0%,while the inventory accuracy rate remained steady at 100.0%.Management time for drug dispensing,picking/returning,billing,and maintenance was reduced by 50.0% to 75.0%.The overall satisfaction score among medical staff was (4.46±0.13) points (maximum score was 5 points),with perceived usefulness receiving the highest rating (4.66±0.23) points. Conclusions This system effectively compensates for the absence of manufacturer-side coding by converting institutional norms into strict system constraints through a "technological enforcement" mechanism.It significantly enhances traceability accuracy and management efficiency,offering a practical and actionable paradigm for intelligent pharmacy management.
The change of active pharmaceutical ingredient (API) suppliers is a relatively common occurrence in post-marketing drug change management of drugs.Due to its high technical requirements and complex related processes,it has always been a key and difficult point in regulatory review.Based on current laws,regulations and technical guidelines,and combined with actual review experience,this paper takes the quality comparability of APIs and their preparations before and after the change as the core,and deeply discusses the changes in critical quality attributes (CQAs),with a focus on core quality indicators such as the crystal form,particle size distribution,impurity profile of APIs and the dissolution curve of preparations.The aim is to provide technical support to regulatory authorities to conduct scientific and standardized reviews,and to offer reference and guidance to marketing authorization holders (MAHs) to conduct change research.